Contact person
Louise Wogelred
Forskare
Contact Louise
Medical Devices – sterility validation
In the Instruction for Users, supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to e.g. EN ISO 17665:2006 (for autoclavation).
Purpose
Contribute to healthcare safety by having clear and validated instructions for sterilization.
Fulfill requirements in MDR.
Method
Sterilization validation is performed by showing a sterility assurance level (SAL) of 10-6 using, for the method, most resistant organism.
When relevant, we can also evaluate that the drying time after sterilisation is enough, to ensure safe storage of the product.
Deliveries
Methods and results are presented in a written report.
